Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion

A Prospective, Randomized, Parallel Pilot Study of Transdermal, Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion

EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).

Study Overview

• Status: Withdrawn
• Conditions: Instrumented Spinal Fusion
• Intervention / Treatment: Device: EPIFLO

Detailed Description

Surgical site infections (SSI) after instrumented spinal fusions are not rare, and patients with SSI after instrumented spinal surgery often require repeat operations and prolonged intravenous antibiotic therapy. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) has recently become a novel strategy to facilitate wound healing.

The study doctor will give an EPIFLO® unit along with standard wound care to some subjects in this study to see if it is safe and can help them. Another purpose of this study is to find out if using EPIFLO® is better than getting only standard wound care for Surgical site infections (SSI). The sponsor also wants to compare the cost of using the study device and standard wound care to the cost of standard wound care alone. The U.S. Food and Drug Administration (FDA) has approved EPIFLO® to treat skin ulcers (including diabetic skin ulcers), bedsores, amputations, skin grafts, burns, and frostbite.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Department of Neurological Surgery Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective spinal fusion - posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions
• Patient Age 18-80

• Patients must be considered high risk for infection, meeting one or more of the following criteria:

  • Anticipated Surgical duration ≥ 3 hours
  • Diabetes Mellitus type I or II
  • Anesthesiology ASA score of 3 or above
  • BMI ≥35
  • Patients with malnutrition as indicated by Pre-albumin value of <20
  • Chronic corticosteroid use
  • Smokers
  • Patients on immune modulators

Exclusion Criteria:

Major Study Exclusion Criteria include:

• Pregnancy
• Active infection at the time of surgery
• Persons with decubitus or diabetic ulcers
• Patients undergoing >5 level fusion (Level is defined as crossing a disk space; e.g.,an L3-5 fusion is a 2 level fusion)
• Disseminated Cancer Patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdermal Continuous Oxygen Therapy; EPIFLO® working study unit, all day, every day for 2 weeks + standard wound care	Device: EPIFLO; Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site.; Other Names: TCOT, Transdermal Continuous Oxygen Therapy
No Intervention: Standard of care; standard wound care for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of surgical site infection	The primary objective of this study is to assess surgical site infection within 3 months of surgery for "high risk" patients undergoing posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control. Surgical site infection will be clinically assessed by the PI according to CDC criteria. Independent blinded assessment by a clinician blinded to the allocation arm will also be obtained. The number of patients with infection (and the severity of infection) in the treated arm will be compared to the number in the control arm.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource utilization	Resource utilization- the sum total of cost of treatments, hospital stays, bandages, nursing care and anything else related to treatment all measured in dollar amounts and then summed	3 months
Severity of infection	Severity of infection - Superficial or deep as per CDC classification as assessed by investigator	3 months

Collaborators and Investigators

• Sponsor: Neogenix, LLC dba Ogenix
• Investigators: Principal Investigator: Nestor Tomycz, M.D., Department of Neurosurgery

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: infection; instrumented spinal fusion; topical oxygen
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: EPF-515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No